Fentanyl Transdermal Patch

What is Fentanyl Transdermal Patch?

• Fentanyl (Duragesic) transdermal system contains fentanyl, an opioid agonist used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications.

Fentanyl

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What are the uses of this medicine?

• Fentanyl (Duragesic) is a strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, in people who are already regularly using opioid pain medicine, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

Limitations of use:

• A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Not for use to treat pain that is not around-the-clock.

• Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

How does this medicine work?

• Fentanyl is an opioid agonist.
• Fentanyl interacts predominately with the opioid mu-receptor.
• These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.

Who Should Not Use this medicine ?

This medicine cannot be used in:

• patients who are not opioid-tolerant.
• the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time.
• the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies).
• the management of mild pain.
• patients with significant respiratory depression.
• in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
• in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
• in patients with hypersensitivity to fentanyl (e.g., anaphylaxis) or any components of the transdermal system.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• amiodarone (Nexterone, Pacerone); aprepitant (Emend); benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion);carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); certain antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral); clarithromycin (Biaxin, in Prevpac); diltiazem (Cardizem, Cartia, Diltzac, Taztia); erythromycin (E-Mycin, Erythrocin); fosamprenavir (Lexiva); medications for mental illness and nausea; other medications for pain; muscle relaxants; nefazodone; nelfinavir (Viracept); phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); ritonavir (Norvir, in Kaletra); sedatives; sleeping pills; tranquilizers; and verapamil (Calan, Covera, Verelan).
• antidepressants; antihistamines (found in cough, cold, and allergy medications); buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol; dextromethorphan (found in many cough medications; in Nuedexta); lithium (Lithobid); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); nalbuphine; pentazocine (Talwin); sedatives; 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), milnacipran (Savella), and venlafaxine (Effexor);trazodone (Oleptro); or tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), trimipramine (Surmontil) and St. John's wort and tryptophan.

• Also tell your doctor or pharmacist if you are taking or receiving the following medications or have stopped taking them within the past 2 weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).

Is this medicine FDA approved?

• Fentanyl was first made by Paul Janssen in 1960 and approved for medical use in the United States in 1968.
• In 2019, it was the 278th most commonly prescribed medication in the United States, with more than a million prescriptions.

How should this medicine be used?

• Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with fentanyl transdermal system.
• Consider prescribing naloxone based on the patient’s risk factors for overdose.

Recommended dosage:

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
• The recommended starting dose when converting from other opioids to fentanyl transdermal system is intended to minimize the potential for overdosing patients with the first dose.
• Each fentanyl transdermal system is worn continuously for up to 72 hours.

Mild to moderate hepatic and renal impairment:

• Initiate treatment with one half the usual starting dose, titrate slowly, and monitor for signs of respiratory and central nervous system depression.

• Do not abruptly discontinue fentanyl transdermal system in a physically-dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

Administration:

• Transdermal fentanyl comes as a patch to apply to the skin. The patch is usually applied to the skin once every 72 hours. Change your patch at about the same time of day every time you change it.
• Your doctor may start you on a low dose fentanyl patch and gradually increase your dose, not more often than once every 3 days at first, and then not more often than once every 6 days.
• Your doctor may decrease your dose if you experience side effects.
• Talk to your doctor about how you are feeling during your treatment with fentanyl patches.
• Fentanyl patches are only for use on the skin.
• Do not place patches in your mouth or chew or swallow the patches.
• Do not stop using fentanyl patches without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop using fentanyl patches you may have symptoms of withdrawal.
• Do not use a fentanyl patch that is cut, damaged, or changed in any way.
• If you use cut or damaged patches, you may receive most or all of the medication at once, instead of slowly over 3 days.
• This may cause serious problems, including overdose and death.
• You may bathe, swim, or shower while you are wearing a fentanyl patch.
• If the patch falls off during these activities, dispose of it properly.
• Then dry your skin completely and apply a new patch.
• Leave the new patch in place for 72 hours after you apply it.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Transdermal system: 12 mcg/hour, 25 mcg/hour, 37.5 mcg/hour, 50 mcg/hour, 62.5 mcg/hour, 75 mcg/hour, 87.5 mcg/hour, 100 mcg/hour.

This medicine is available in fallowing brand namesː

• Duragesic

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, itching, redness, or rash where the patch is applied.

Transdermal fentanyl may cause serious side effects which may include:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

What special precautions should I follow?

• Using fentanyl transdermal system with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) may cause severe drowsiness, decreased awareness, breathing difficulties, with slow or shallow breathing, coma, and death.
• Never give anyone else your fentanyl transdermal system. They could die from using it. Selling or giving away fentanyl transdermal system is against the law.
• Store fentanyl transdermal system, securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
• If the patch accidentally sticks to a family member while in close contact, take the patch off, wash the area with water, and get emergency help right away because an accidental exposure to fentanyl transdermal system can lead to death or other serious medical problems.
• Dispose of expired, unwanted, or unused fentanyl transdermal system, by folding the patch so that the adhesive side of the patch adheres to itself, and immediately flushing down the toilet
• Do not take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps, or engage in exercise that increases your body temperature. These can cause an overdose that can lead to death.
• Do not drive or operate heavy machinery, until you know how fentanyl transdermal system affects you. Fentanyl transdermal system can make you sleepy, dizzy, or lightheaded.
• Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with fentanyl transdermal system may cause you to overdose and die.
• Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status.
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper.
• Prolonged use of fentanyl transdermal system during pregnancy can result in withdrawal in the neonate. Advise pregnant women of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
• Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death as a result of exposure to heat. Warn patients to avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources.
• Serum fentanyl concentrations could theoretically increase by approximately one-third for patients with a body temperature of 40°C (104°F). Monitor patients with fever closely for sedation and respiratory depression and reduce the dose if necessary. Warn patients to avoid strenuous exertion that may lead to increased body temperature.
• Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue fentanyl transdermal system immediately if serotonin syndrome is suspected.
• Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
• Fentanyl transdermal system may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Monitor during dose initiation and titration. Avoid the use of fentanyl transdermal system in patients with circulatory shock.
• Fentanyl patches may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using fentanyl patches.
• In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), fentanyl transdermal system may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor for sedation and respiratory depression. Avoid use of fentanyl transdermal system in patients with impaired consciousness or coma.
• Fentanyl transdermal system may produce bradycardia. Monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating therapy with fentanyl transdermal system.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.
• Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Give primary attention to the reestablishment of a patent airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques. Once stable, examine the patient and ensure that all fentanyl transdermal systems have been removed.
• Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose.
• In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome.
• If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

Can this medicine be used in pregnancy?

• Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome.
• Available data with fentanyl transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.
• Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Can this medicine be used in children?

• The safety and effectiveness of fentanyl transdermal system in children under 2 years of age have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• FENTANYL

Inactive Ingredients:

• DIMETHICONE
• TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE

Who manufactures and distributes this medicine?

Manufactured for:

• Mylan Pharmaceuticals Inc.
• Morgantown, WV U.S.A.

What should I know about storage and disposal of this medication?

• Store in original unopened pouch. Store at 20° to 25°C (68° to 77°F).
• Store fentanyl transdermal system securely and dispose of properly.

• Dailymed label info on Fentanyl Transdermal Patch
• FDA Fentanyl Transdermal Patch

Fentanyl Transdermal Patch Resources
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